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Time not to be extended to challenge marketing authorisation of ‘generic’ medicinal product

By: Mark Tottenham BL

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Court of Appeal dismisses appeal from High Court, and affirms refusal to extend time to seek leave to apply for judicial review of a decision by the Health Products Regulatory Authority (HPRA) to grant marketing authorisation for a 'generic' medicinal product, where the producer of the original product claimed that it did not comply with the statutory requirements of a 'generic' product, on the grounds that: (a) the decision of the HPRA took effect from the date of the decision, not the date of publication, so the date of formal publication was not strictly relevant to the running of the time limit; (b) the producer of the original product had not taken reasonable steps to acquaint itself with the manner of publication of HPRA decisions, or it would have been better prepared to deal with the situation; and (c) the producer of the original product did not act with the appropriate speed on learning of the decision.

Murray J (nem diss): Regulation of medicines - veterinary product - Cartrophen - treatment of osteoarthritis in dogs - requirement of EU marketing authorisation - authorisation granted by Health Products Regulatory Authority (HPRA) in 1991 - European Communities (Animal Remedies) (No. 2) Regulations 2007 (SI No. 786 of 2007) - authorisation granted in 2018 for another 'generic' product - Osteopen - same qualitative and quantitative composition and active substances in the same pharmaceutical form as a reference product that has been previously authorised - producer of original product learned of authorisation after it had been granted - leave to apply for judicial review - whether new product was properly viewed as a generic of the original product - whether composition of two products was the same - omission of bioequivalence data in course of process - whether new product should have been assessed in accordance with Article 13(4) of the Directive owing to use of biological substance as an active ingredient - whether application for leave was outside time limit - refusal of High Court to extend time - point from which time began to run - publication of decision - legal characterisation of Arthropharm’s interest in the impugned decision - product valid from the date of authorisation - whether to extend time - different manufacturing processes - letter following authorisation seeking a review of the registration process - objections in other EU states and other jurisdictions - provisions governing extensions of time to seek judicial review - whether engagement in correspondence with a decision maker could ever ground an application for an extension of time.

Note: This is intended to be a fair and accurate report of a decision made public by a court of law. Any errors should be notified to the editor and will be dealt with accordingly.

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